Dextenza NDA resubmitted

Dextenza (dexamethasone insert) 0.4 mg, for the treatment of ocular pain occurring after ophthalmic surgery, has been resubmitted to U.S. regulators for approval, developer Ocular Therapeutix (Bedford, Massachusetts) said in a press release. Dextenza is administered by a physician as a bioresorbable intracanalicular insert and designed for drug release to the ocular surface for up to 30 days, the company said. Ocular Therapeutix resubmitted its New Drug Application (NDA) in response to a complete response letter received from the Food and Drug Administration in July 2016, which identified items pertaining to deficiencies in manufacturing process and controls. Ocular Therapeutix thinks that the FDA review period of the resubmission will be up to 2 months if a Class 1 (minor review) designation is received and up to 6 months if a Class 2 (major review) designation is received. Class 1 or 2 designation is dependent on whether an FDA reinspection of the Ocular Therapeutix manufacturing facility will be a condition of approval.

GCA drug candidate granted priority review

The Food and Drug Administration has granted priority review to Actemra (tocilizumab) for the treatment of giant cell arteritis (GCA), a chronic, potentially life-threatening autoimmune condition that can cause severe headaches, jaw pain, and visual symptoms and if left untreated, can lead to blindness, aortic aneurysm, or stroke, developer Genentech (South San Francisco) said in a press release. Tocilizumab is the first humanized interleukin-6 receptor antagonist approved for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have used one or more disease-modifying antirheumatic drugs, such as methotrexate, that did not provide enough relief. The designation is based on positive outcomes from the Phase 3 GiACTA study that found tocilizumab, initially combined with a 6-month steroid (glucocorticoid) regimen, more effectively sustained remission through 1 year compared to a 6- or 12-month steroid taper regimen given alone in people with GCA.

Nicox finalizing NCX 470 study details

A first-in-human study for NCX 470, a Phase 2 multicenter, investigator masked, 28-day, parallel group, dose-finding study in adult subjects with elevated intraocular pressure (IOP) due to open angle glaucoma or ocular hypertension, should begin in about a year, developer Nicox (Sophia Antipolis, France) said in a press release. Multiple doses of NCX 470 will be compared in safety and efficacy to bimatoprost in the study, Nicox said. The primary endpoint is the mean reduction in IOP, and the objective is to identify the appropriate safe and effective dose of NCX 470 to be taken into Phase 3 studies. Patient recruitment is expected to begin in early 2018, subject to Investigational New Drug filing and acceptance, and the study is expected to take approximately 1 year to complete.

Ocriplasmin, robotics used to dissolve blot clots in RVO

Surgeons at the University Hospitals Leuven and the University of Leuven, Belgium, have developed a surgical robot that uses a needle of barely 0.03 mm to inject a thrombolytic drug (ocriplasmin) into the retinal vein of the patient to dissolve a blood clot, according to a news release. A Phase 2 trial now has to show what the clinical effect is for patients with retinal vein occlusion (RVO), the group announced. Retinal vein cannulation (RVC) is "a revolutionary treatment that addresses the cause of RVO by removing the blood clot in the retinal vein," the group said. Human surgeons are unable to manually inject a drug into such a thin vein while holding the needle perfectly still for 10 minutes; the robotic device overcomes this obstacle.

RESEARCH BRIEFS

Higher corneal hysteresis (CH) in glaucoma-like optic discs (GLD) and ocular hypertension (OHT) compared to glaucoma suggests increased viscoelasticity of ocular tissues may have a protective role against glaucoma, according to Melissa Murphy and colleagues. They compared CH among patients with glaucoma, OHT, and GLD (the latter of which was defined as a cup to disc ratio greater than or equal to 0.6 with normal IOP and visual fields) in 123 eyes (123 patients). Mean CH was significantly higher for GLD compared to glaucoma (mean difference 1.83, p<0.001), and significantly higher for OHT compared to glaucoma (mean difference 2.35, p<0.001). Mean CH was slightly lower in patients with GLD than those with OHT, but this difference was not statistically significant. A similar pattern was seen when the analysis was repeated for corneal resistance factor and central corneal thickness. The study is published in BMC Ophthalmology.

Tear function is significantly disturbed in idiopathic dacryoadenitis, according to a study. K. Xue and colleagues enrolled 16 subjects and divided them into three groups: patients with idiopathic dacryoadenitis with affected sites (group 1), with contralateral sites (group 2), and healthy participants (group 3). Tear meniscus height and tear meniscus area were the lowest in patients with affected sites (group 1) among the three groups (p<0.05). Breakup time was the shortest in group 1 (p<0.05). In group 1, breakup time, fluorescein staining score, and histopathological phases were significantly correlated with tear meniscus height and tear meniscus area (p<0.05). The study is published in Ophthalmic Plastic and Reconstructive Surgery.

Nonsteroidal anti-inflammatory drugs (NSAIDs) and steroids do not create significant difference in the conformational changes of cataract wounds when administered postoperatively, according to Eun Young Choi, MD, and colleagues. In their prospective, randomized, comparative study, eyes undergoing cataract surgery in South Korea were randomly given an NSAID (bromfenac 0.1%; n=29) or a steroid (prednisolone acetate 1.0%; n=30). Using anterior segment optical coherence tomography (AS-OCT), structural changes of clear corneal incisions were examined 1 day and 1, 3.5, and 23 weeks postoperatively. During the 6-month follow-up, the overall changes in wound instability were not significantly different between groups, although epithelial detachment or a larger defect was more frequent in the bromfenac group between 1 week and 3.5 weeks postoperatively. The surgically induced astigmatism at 1 week was positively correlated with wound instability, and wound instability at 1 day was positively correlated with cataract grading in both groups. The study is published in the Journal of Cataract & Refractive Surgery.

EyeWorld Week Online (ISSN 1089-0319), a digital publication
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the American Society of Ophthalmic Administrators, is published
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